Tissue fixation system and method

ABSTRACT

A tissue fixation system is provided for dynamic and rigid fixation of tissue. A fastener connected with an elongate fastening member, such as a cable, wire, suture, rod, or tube, is moved through a passage between opposite sides of tissue. The fastener is provided with a groove that accommodates at least a portion of the fastening member to reduce the profile during the movement through the passage. The fastener is then pivoted to change its orientation. A second fastener can then be connected with the fastening member. While tension is maintained in the fastening member, the fasteners are secured against relative movement. This may be done by deforming the fastening member, either the first or second fasteners, or a bushing placed against the second fastener.

CROSS-REFERENCE TO RELATED APPLICATION

This Application claims the benefit of U.S. Provisional PatentApplication No. 60/655,140, filed Feb. 22, 2005, entitled TISSUEFIXATION SYSTEM AND METHOD, the content of which is incorporated byreference in its entirety.

FIELD OF THE INVENTION

The invention relates to a system and method for fixation andstabilization of tissue. In particular, the invention relates tominimally invasive bone fracture fixation and stabilization.

BACKGROUND OF THE INVENTION

It is well-known in the medical arts that applying pressure to tissuehelps during the healing process. Incised or torn soft tissue, forexample, may be approximated with bandages, sutures, or staples. Properand more rapid healing of broken or fractured bones likewise may befacilitated by applying constant pressure to the bone. For instance,physicians may insert pins, screws, or bolts in the area of the fracturein order to apply pressure to the fracture.

However, inserting screws through or around fractures can be complex andtime-consuming. For example, the process of inserting a screw typicallyinvolves multiple steps conducted from multiple incisions or openingsthat provide access to the treated bone or tissue, including the stepsof drilling holes, measuring the relevant distances to determine theappropriate screw selection, tapping the hole to establish threads, andscrewing the screw into the hole.

In addition to the length and complexity of the process, bone screwsalso may lose their grip and strip out of the bone. In addition,currently available lag screws also typically provide only one side ofcortex fixation and are generally not suited for percutaneous surgery.Moreover, when placing the screws in the bone, the physician may notaccurately set the screw into the distal hole or may miss the distalhole completely, thereby resulting in the screw stripping the threads orbreaking the bone.

Many devices and instruments have been disclosed to fasten soft and hardtissue for enhanced healing or tissue reconstruction. Examples of suchdevices include bone plates, bone wraps, external bone supports, and thelike.

For example, U.S. Pat. No. 5,921,986, the contents of which areincorporated herein by reference, discloses a bone suture and associatedmethods for implantation and fracture fixation. The '986 Patentdescribes fasteners and anchors used in conjunction with an elongatefixation element, such as a suture. In some cases, it may beadvantageous to use more rigid fixation elements.

Accordingly, a need exists for a tissue fixation instrument which canprovide flexible or rigid fixation of tissue while accessing the tissuefrom a small skin portal.

SUMMARY OF THE INVENTION

The present invention relates to a tissue fixation system. The systemcomprises an elongate fastening member and a fastener moveable withrespect to the elongate fastening member from a first orientation to asecond orientation, the fastener having a body with a tissue contactingsurface that includes a groove configured and dimensioned to receive aportion of the elongate member in the first orientation. The system canalso include a second fastener or other means for maintaining tension inthe elongate fastening member.

A biasing means can be provided to maintain the fastener in the firstorientation. The biasing means can be an adhesive between the groove andthe portion of the elongate fastening member received in the groove. Thebiasing means could also be a frangible connection between the grooveand the portion of the elongate fastening member received in the groove.

The fastener body can have a free surface opposite the tissue contactingsurface, with the free surface including a channel configured anddimensioned to receive a portion of the elongate member in the firstorientation. The fastener body can also include a through bore extendingfrom the tissue contacting surface through the free surface.

In one embodiment, the fastener body includes leading and trailing ends.The leading end can be tapered or otherwise shaped to facilitateinsertion. The groove terminates at the through bore and extends towardone of the leading and trailing ends and the channel terminates at thethrough bore and extends toward the other of the leading and trailingends. In an exemplary embodiment, the groove extends toward the leadingend and the channel extends toward the trailing end.

The free surface of the fastener body can be provided with a wellsurrounding the through bore. The well can be configured and dimensionedto receive at least a portion of the stop. A distal end of the elongatefastening member can include a stop larger than the through bore.

The present invention also relates to a medical instrument or device forsecuring the fastener with respect to the elongate fastening member. Themedical device tensions the elongate fastening member and crimps eitherthe fastener or a bushing. Another aspect of the invention relates tomethods of tissue fixation using the disclosed tissue fixation systems.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 shows a schematic illustration of a tissue fixation systemaccording to the present invention utilized for fracture fixation;

FIG. 2 shows a perspective view of a fastener according to the presentinvention;

FIG. 3 shows a side view of the fastener of FIG. 2;

FIG. 4 shows a bottom view of the fastener of FIG. 2;

FIG. 5 shows a top view of the fastener of FIG. 2;

FIG. 6 shows a fastener and elongate fastening member with the fastenerin a first orientation with respect to the elongate fastening member;

FIG. 7 shows a front view of a fastener in the first orientation withrespect to the elongate fastening member with the fastener rotated 180°compared to FIG. 6;

FIG. 8 shows a back view of the fastener and elongate fastening memberof FIG. 7;

FIG. 9A shows an elongate fastening member according to the presentinvention;

FIG. 9B shows an elongate fastening member including expandable members;

FIG. 10 shows a fastener in a second orientation with respect to anelongate fastening member;

FIG. 11 shows a cannulated drill system used to create a passage throughthe tissue to be fixed;

FIG. 12 shows a sleeve having a lumen through which the fixation systemcan be passed;

FIG. 13 shows a distal fastener being inserted into the sleeve;

FIG. 14 shows a pushrod used to move the distal fastener through thesleeve;

FIG. 15 shows the distal fastener in the second orientation;

FIG. 16 shows a proximal fastener being used to maintain the tension inthe elongate fastening member;

FIG. 17 depicts a front isometric view of the medical device of thepresent invention;

FIG. 18 depicts a rear partial isometric view showing the tensioningmechanism of the medical device of FIG. 17;

FIG. 19 depicts a rear isometric view showing the tensioning mechanismof the medical device of FIG. 17;

FIG. 20 depicts an isometric view of the crimping mechanism collett ofthe medical device of FIG. 17;

FIG. 21 depicts a partial isometric view showing the handle portion ofthe crimping mechanism of the medical device of FIG. 17;

FIG. 22 depicts a top sectional view of the crimping mechanism collettcloser of the medical device of FIG. 17;

FIG. 23 depicts a partial isometric view showing the cutting mechanismof the medical device of FIG. 17;

FIG. 24 depicts a partial isometric view showing the collett portion ofthe cutting mechanism of FIG. 23;

FIG. 25 depicts an isometric view showing the cutting arm of the cuttingmechanism of FIG. 24;

FIG. 26 depicts the medical device of FIG. 17 in use to secure a bonefracture;

FIG. 27 depicts a front isometric view of an alternative medical deviceof the present invention;

FIG. 28 depicts an isometric view of the crimping mechanism collett ofthe medical device of FIG. 27;

FIG. 29 depicts an isometric view of the crimping mechanism collettcloser of the medical device of FIG. 27;

FIG. 30 depicts a sectional view of the medical device of FIG. 27 in useto secure a bone fracture;

FIG. 31 depicts an exemplary fastener for use with the medical device ofFIG. 27;

FIG. 32 depicts an alternative sectional view of the medical device ofFIG. 27 in use to secure a bone fracture;

FIG. 33 depicts an alternative fastener for use with the medical deviceof FIG. 32;

FIG. 34 depicts an alternative cable tensioner for the medical device ofFIG. 17;

FIG. 35 depicts a sectional view of the cable tensioner of FIG. 34;

FIG. 36 depicts a front isometric view of the medical device of thepresent invention;

FIG. 37 depicts a side sectional view showing the tensioning mechanismof the medical device of FIG. 36;

FIG. 38 depicts a rear exploded view showing the tensioning mechanism ofthe medical device of FIG. 36;

FIG. 39 depicts an isometric view of the crimping mechanism collett ofthe medical device of FIG. 36;

FIG. 40 depicts a partial isometric view showing the handle portion ofthe crimping mechanism of the medical device of FIG. 36;

FIG. 41 depicts a partial isometric view showing the cutting mechanismof the medical device of FIG. 36;

FIG. 42 depicts an isometric view of the cutting mechanism in thecollett of the medical device of FIG. 36;

FIG. 43 depicts the cutting wedge of the medical device of FIG. 36; and

FIG. 44 depicts a safety lock of the medical device of FIG. 36.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a tissue fixation system for dynamic andrigid fixation of tissue. The system can be utilized for the fixationand stabilization of body tissue, including soft tissue to soft tissue,soft tissue to bone, and bone to bone. The surgical system canadditionally be used to affix implants and grafts to body tissue. Thesystem can access and treat fractured, incised or torn tissue, or thelike, from one access area (i.e., from only one opening to the tissue tobe fastened) instead of requiring two or more openings. That is, thesystem is a linear fixation system that can be used with a single, smallincision or portal in the skin or other soft tissue to gain access tothe fractured bone. The fixation system may be an all-in-one system,packaged as a system kit, for creating a passage in tissue, positioningfasteners, and tensioning an elongate fastening member, like a suture,thread, cable, wire, rod, or pin. The individual components of thesystem can either be reusable or single use components.

Referring now to the drawing figures in which like reference designatorsrefer to like elements, FIG. 1 shows an exemplary embodiment of a tissuefixation system 100 according to the present invention. A fracturedportion 102 of a bone 104 is approximated by system 100. Use of system100 is not limited to any particular type of fracture. Furthermore, useof system 100 is not limited to fracture fixation. In other words,system 100 can be utilized for other tissue fixation applications (suchas soft tissue) or similar clinical indications. Examples of such tissueincludes, are not limited to, muscle, cartilage, ligament, tendon, skin,etc. Also, the tissue may be stomach tissue, and the system may be usedduring bariatric surgery, like stomach stapling. Additionally, thesystem 100 can be used for the fixation of implants to tissue.

In this regard, the present invention may be used in conjunction withany surgical procedure of the body. The repair, reconstruction,augmentation, and securing of tissue or an implant may be performed inconnection with surgery of a joint, bone, muscle, ligament, tendon,cartilage, capsule, organ, skin, nerve, vessel, or other body part. Forexample, tissue may be repaired, reconstructed, augmented, and securedfollowing intervertebral disc surgery, knee surgery, hip surgery, organtransplant surgery, bariatric surgery, spinal surgery, anterior cruciateligament (ACL) surgery, tendon-ligament surgery, rotator cuff surgery,capsule repair surgery, fractured bone surgery, pelvic fracture surgery,avulsion fragment surgery, hernia repair surgery, and surgery of anintrasubstance ligament tear, annulus fibrosis, fascia lata, flexortendons, etc. In one particular application, an anastomosis is performedover a balloon and the methods and devices of the present invention areused to repair the vessel.

Also, tissue may be repaired after an implant has been inserted withinthe body. Such implant insertion procedures include, but are not limitedto, partial or total knee replacement surgery, hip replacement surgery,bone fixation surgery, etc. The implant may be an organ, partial organgrafts, tissue graft material (autogenic, allogenic, xenogenic, orsynthetic), collagen, a malleable implant like a sponge, mesh,bag/sac/pouch, collagen, or gelatin, or a rigid implant made of metal,polymer, composite, or ceramic. Other implants include breast implants,biodegradable plates, porcine or bovine patches, metallic fasteners,compliant bearing for medial compartment of the knee, nucleus pulposusprosthetic, stent, tissue graft, tissue scaffold, biodegradable collagenscaffold, and polymeric or other biocompatible scaffold. The scaffoldmay include fetal cells, stem cells, embryonal cells, enzymes, andproteins.

The present invention further provides flexible and rigid fixation oftissue. Both rigid and flexible fixation of tissue and/or an implantprovides compression to enhance the healing process of the tissue. Afractured bone, for example, requires the bone to be realigned andrigidly stabilized over a period time for proper healing. Also, bonesmay be flexibly secured to provide flexible stabilization between two ormore bones. Soft tissue, like muscles, ligaments, tendons, skin, etc.,may be flexibly or rigidly fastened for proper healing. Flexiblefixation and compression of tissue may function as a temporary strut toallow motion as the tissue heals. Furthermore, joints which include hardand soft tissue may require both rigid and flexible fixation to enhancehealing and stabilize the range of motion of the joint. Flexiblefixation and compression of tissue near a joint may provide motion inone or more desired planes. The fasteners described herein andincorporated by reference provide for both rigid and flexible fixation.

Although the invention is described primarily on a macroscopic level, itis also envisioned that the present invention can be used formicroscopic applications. For example, in the repair of nerve tissue,individual cells or fibers may need to be repaired. Similarly, musclerepair may require tightening of individual muscle fibers.

System 100 includes a distal fastener 106 contacting fracture portion102, a proximal fastener 108 contacting bone 104, and an elongatefastening member 110 extending through the fracture and coupling distaland proximal fasteners 106, 108. Tension is maintained in elongatefastening member 110 to press fasteners 106, 108 against opposite sidesof bone 104 with a desired force. This force presses fracture portion102 against bone 104 firmly together to promote healing of the fracture.If desired, buttons or other force distributing members could beprovided between fasteners 106, 108 and the bone. Although FIG. 1 showsdistal and proximal fasteners 106, 108 as having the same construction,they could have differing construction. However, for convenience andpractical purposes, it may be beneficial if distal and proximalfasteners 106 and 108 have substantially the same construction.

FIGS. 2-5 show an exemplary embodiment of a fastener 112 that can beused as part of system 100, i.e. as either or both of distal andproximal fasteners 106, 108. Fastener 112 has a body 114 that isconfigured and dimensioned to facilitate implantation through minimallyinvasive procedures, e.g. through a cannula or sleeve. In particular,body 114 includes a tissue contacting surface 116 that is provided withgroove 118 that receives a portion of elongate fastening member 110 whenfastener 112 is in a first orientation with respect to elongatefastening member 110. This is seen in FIG. 6. The accommodation ofelongate fastening member 110 within groove 118 helps to minimize theprofile of the assembly of fastener 112 and elongate fastening member110. The reduced profile can be more readily passed through a cannula orsleeve. If desired, an adhesive can be provided within groove 118 tobias fastener 112 in the first orientation. Alternatively, a frangibleconnection can be provided between groove 118 and the portion ofelongate fastening member 110. This frangible connection keeps fastener112 in the first orientation with respect to elongate fastening member110 until it is broken.

Fastener 112 is provided with first and second ends 120, 122. As shownin FIG. 6, first end 120 is the leading end and second end 122 is thetrailing end. In this position, when fastener 112 is pivoted to a secondorientation, like distal fastener 106 of FIG. 1, tissue contactingsurface 116 is in contact with the tissue. As shown in FIGS. 7 and 8,second end 122 is the leading end and first end 120 is the trailing end.In this position, when fastener 112 is pivoted to the secondorientation, like proximal fastener 108 of FIG. 1, tissue contactingsurface 116 is in contact with the tissue.

Fastener body 114 has a free surface 124 opposite tissue contactingsurface 116. Free surface 124 is provided with a channel 126 thatreceives a portion of elongate fastening member 110 when fastener 112 isin a first orientation with respect to elongate fastening member 110. Asshown in FIGS. 7 and 8, fastener 112 is being slid along elongatefastening member 110. In particular, a through bore 128 extends fromtissue contacting surface 116 through free surface 124. Through bore 128is larger in diameter than elongate fastening member 110 so thatfastener 112 freely slides along elongate fastening member 110. Aportion of elongate fastening member 110 fits within channel 126 on freesurface 124 and a portion of elongate fastening member 110 fits withingroove 118 on tissue contacting surface 116.

Fastener body 114 is shown with first end 120 having a substantiallyflat profile and second end 122 having a tapered profile. In general,any suitable external configuration can be used for fastener 112.Examples of fasteners may be found in U.S. Pat. Nos. 5,163,960;5,403,348; 5,464,426; 5,549,630; 5,593,425; 5,713,921; 5,718,717;5,782,862; 5,814,072; 5,814,073; 5,845,645; 5,921,986; 5,948,002;6,010,525; 6,045,551; 6,159,234; 6,368,343; 6,447,516; 6,475,230;6,592,609; 6,635,073; and 6,719,765. Other fastener types are disclosedin U.S. patent application Ser. Nos. 10/102,413; 10/228,855; 10/779,978;10/780,444; and Ser. No. 10/797,685. The above cited patents and patentapplications are hereby incorporated by reference.

Fastener 112 can be made of any biocompatible material suitable for agiven application. For example, the fasteners may be, but are notlimited to, degradable, biodegradable, bioerodible, bioabsorbable,mechanically expandable, hydrophilic, bendable, deformable, malleable,riveting, threaded, toggling, barbed, bubbled, laminated, coated,blocking, pneumatic, one-piece, multi-component, solid, hollow,polygon-shaped, pointed, self-introducing, and combinations thereof.Also, the fasteners may include metallic material, polymeric material,ceramic material, composite material, body tissue, synthetic tissue,hydrophilic material, expandable material, compressible material, heatbondable material, and combinations thereof. Examples of body tissueinclude bone, collagen, cartilage, ligaments, or tissue graft materiallike xenograft, allograft, and autograft. The fasteners may also be madefrom a porous matrix or mesh of biocompatible and bioresorbable fibersacting as a scaffold to regenerate tissue.

The fasteners may further be made of or have a coating made of anexpandable material. The material could be compressed then allowed toexpand. Alternatively, the material could be hydrophilic and expand whenit comes in contact with liquid. Examples of such expandable materialsare ePTFE and desiccated body tissue.

Moreover, the fasteners described herein and incorporated by referencemay include therapeutic substances to promote healing. These substancescould include antibiotics, hydroxyapatite, anti-inflammatory agents,steroids, antibiotics, analgesic agents, chemotherapeutic agents, bonemorphogenetic protein (BMP), demineralized bone matrix, collagen, growthfactors, autogenetic bone marrow, progenitor cells, calcium sulfate,immo suppressants, fibrin, osteoinductive materials, apatitecompositions, germicides, fetal cells, stem cells, enzymes, proteins,hormones, cell therapy substances, gene therapy substances, andcombinations thereof. These therapeutic substances may be combined withthe materials used to make the fasteners to produce a compositefastener. Alternatively, the therapeutic substances may be impregnatedor coated on the fastener. Time-released therapeutic substances anddrugs may also be incorporated into or coated on the surface of thefastener. The therapeutic substances may also be placed in abioabsorbable, degradable, or biodegradable polymer layer or layers.

FIG. 9A shows an exemplary embodiment of an elongate fastening member130. Elongate fastening member 130 includes a body 132 and has a stop134 at a distal end. Body 132 can be selected for a given application.For example, if a rigid elongate fastening member 130 is needed, body132 can be a rod or a tube. If a more flexible elongate fastening member130 is needed, body 132 can be a suture. In general, a wire analogous tothose used for cerclage of bone fractures is believed to provide asuitable combination of strength and flexibility. Although body 132 isshown as a single strand wire, the invention can be used with any typeof surgical cable, such as a multi-strand cable.

Stop 134 can be made integral with body 132 or separate and thenattached. Stop 134 is larger in diameter than through bore 128 in body114 of fastener 112. Thus, once stop 134 reaches through bore 128,fastener 112 cannot be slid any further along elongate fastening member130. As shown in FIG. 5, free surface 124 of fastener 112 is providedwith a well 136 surrounding through bore 128. Well 136 is configured anddimensioned to receive at least a portion of stop 134. As shown in FIG.10, this helps reduce the profile of the assembly when fastener 112 isin a second orientation with respect to elongate fastening member 130.

Referring to FIG. 9B, in another embodiment, the elongated fastenermember 130 includes expandable members 131, positioned along the body132. Upon insertion into the tissue, the expandable members 131 expandto engage the surrounding tissue. For examples, the expandable members131 can be barbs. The barbs 131 engage the surrounding tissue,maintaining the elongated fastener member's 130 position within thetissue.

The elongate fastening members of the present invention may be made ofmetallic material, non-metallic material, composite material, ceramicmaterial, polymeric material, co polymeric material, or combinationsthereof. The members may be degradable, biodegradable, bioabsorbable, ornonbiodegradable. Examples of suture materials that can be used for theelongate fastening members are polyethylene, polyester, cat gut, silk,nylon, polypropylene, linen, cotton, and copolymers of glycolic andlactic acid. Preferably, the members are flexible or bendable. They maybe threadlike, monofilament, multifilament, braided, or interlaced. Themembers may have a coating of therapeutic substances or drugs. Forexample, the members may include antibiotics, hydroxyapatite,anti-inflammatory agents, steroids, antibiotics, analgesic agents,chemotherapeutic agents, bone morphogenetic protein, demineralized bonematrix, collagen, growth factors, autogenetic bone marrow, progenitorcells, calcium sulfate, immo suppressants, fibrin, osteoinductivematerials, apatite compositions, fetal cells, stem cells, enzymes,proteins, hormones, and germicides.

The use of the tissue fixation system according to the present inventionwill now be described using fracture fixation as an example. Ifnecessary, the fracture is reduced bringing fracture portion 102 intocontact with bone 104 (FIG. 11). The reduction can be achieved using anynumber of techniques.

As also shown in FIG. 11, a drill system 138 is used to drill across thefracture, thereby creating a passage completely through bone 104. Drillsystem 138 includes a drill bit 140 with a headpiece configured forattachment to a drill. A drill stop can be placed on the headpiece andprevents drill bit 140 from penetrating too far beyond the tissue to bedrilled. Drill system 138 may be a cannulated drill system that fitsover a k-wire or other similar guide wire. A cannula or sleeve 142 mayencircle drill bit 140 or at least the shaft portion of drill bit 140.As drill bit 140 creates a passage through bone 104, sleeve 142 ispositioned in the passage. Drill system 138 is used to create a passagein bone 104 from the proximal side of bone 104 to the distal side ofbone 104, then the drill and drill bit 140 are removed from sleeve 142(FIG. 12).

As shown in FIG. 13, a distal fastener 112 a is inserted into sleeve142. Distal fastener 112 a is inserted in the first orientation withrespect to elongate fastening member 130 with first end 120 as theleading end. In this configuration, tissue contacting surface 116 willbe in contact with fracture portion 102 when distal fastener 112 a ispivoted into the second orientation. This is best seen in FIGS. 14 and15, in which a pushrod 144 is used to advance distal fastener 112 a andelongate fastening member 130 through sleeve 142. Pushrod 144 alsofacilitates the pivoting of distal fastener 112 a from the firstorientation to the second orientation. This pivoting is not possibleuntil distal fastener 112 a has exited through sleeve 142. Also, sincethe length of distal fastener 112 a is larger than the passage createdin bone 104, pulling back on elongate fastening member 130 helps toensure distal fastener 112 a is in the second orientation and flushagainst fracture portion 102.

As illustrated in FIG. 16, sleeve 142 is removed from bone 104. Fastener112 a is located on the distal side of bone 104. Elongate fasteningmember 130 extends from fastener 112 a through the bone passage and outthe proximal opening of the bone or tissue passage. Any suitable meanscan be used to keep distal fastener 112 a against fracture portion 102with tension, where the tension can be measure and controlled inaccordance with use. For example, elongate fastening member 130 can bedeformed at the proximal end of the passage such that the deformedsection rests against bone 104. The deformation would depend on thenature of elongate fastening member 130. If elongate fastening member130 is a relatively flexible element, such as a suture, cable, or wire,then simply tying a knot in fastening member 130 could be sufficient tomaintain the tension. If elongate fastening member 130 does not allow aknot, such as would be the case with a rod or tube, then mechanicaldeformation of elongate fastening member 130 to create an enlarged headcould be sufficient to maintain the tension. U.S. Patent ApplicationPublication No. US 2002/0016593, the contents of which are incorporatedherein by reference, discloses mechanisms to mechanically deform anextension member and could be used to deform elongate fastening member130.

Alternatively, the elongated fastening member 130 can be deformed by anenergy, such as thermal energy, to deform elongate fastening member 130to create an enlarged head sufficient to maintain the tension.

In an exemplary embodiment, a proximal fastener 112 b is used to securedistal fastener 112 a and elongate fastening member 130. In thisembodiment, proximal fastener 112 b is identical to distal fastener 112a. If not already pre-loaded, proximal fastener 112 b is loaded ontoelongate fastening member 130. Proximal fastener 112 b is loaded asshown in FIGS. 7 and 8, i.e. with second end 122 as the leading end sothat after proximal fastener 112 b is slid down against bone 104 andpivoted into the second orientation, tissue contacting surface 116 is incontact with bone 104.

Elongate fastening member 130 is tensioned, and proximal fastener 112 bis secured to elongate fastening member 130 to thereby approximate thefracture and stabilize bone 104. The tension of elongate fasteningmember 130 pulls on distal and proximal fasteners 112 a, 112 b generallytoward each other, thereby applying pressure to the fractured bone ortissue. In this regard, a bushing 146 can be used to secure proximalfastener 112 b with the desired tension. Single or multiple elongatedmembers 130 can be used to secure the fractured bone or tissue.

Although a number of mechanisms can be used to secure bushing 146, aninstrument or medical device particularly useful for this will now bedescribed.

In this regard, the present invention also provides a medical device forsecuring a fastener against relative movement with respect to a cable.As previously disclosed, a cable and pair of oppositely spaced fastenerscan be used to secure a bone facture. The cable is passed through thebone and fracture; a first fastener secures the cable on a first side(fracture side) of the bone; and a second fastener is positioned aboutthe cable on a second side of the bone, opposite the first fastener. Abushing is positioned onto the cable to secure the second fasteneragainst the second side of the bone. A force is applied to the bushing,compressing the second fastener against the second side of the bone andproviding a tension to the cable. The tension in the cable can bemeasured and controlled, for example, with the used of a sensor andspring element. The spring can apply the force to tension the cable, andthe sensor can be used to measure the resulting tension. Alternatively,the sensor can measure the compression of the tissue to determine thetension. The bushing is crimped about the cable, securing the secondfastener against the second side of the bone, such that a tension isprovided through the cable between the first and second fasteners.

Referring to FIG. 17, a medical device 200 is provided for securing thebushing to the cable. The medical device 200 includes a handle portion202 having a tensioning mechanism 204, tensioning the cable and applyinga force to the bushing, and a crimping mechanism 206 for securing thebushing to the cable.

Referring also to FIGS. 18 and 19, the tensioning mechanism 204 includesa collett holder 208 defining a longitudinal passage along a centrallongitudinal axis A. The collett holder 208 is affixedly positionedthrough a top portion 212 of the handle portion 202 with collett holderpin 214. A cable tensioner 216 is slidably positioned on a first end 218of the collett holder 208. The cable tensioner 216 defines a cablepassage longitudinally aligned with the longitudinal passage of thecollett holder 208. An end portion 222 of the cable tensioner 216includes a cable aperture 224 for threading the cable there through. Aradial groove 226 and circumferential groove 228 are provided on the endportion 222 of the cable tensioner 216, such that the cable can bewrapped about the circumferential groove 228 of the cable tensioner 216,thereby preventing relative movement between the cable and the cabletensioner 216.

A cable tension lever 230 is pivotally connected to the cable tensioner216 with a lever pin 232. The cable tension lever 230 is adjustablypositioned on the handle portion 202 with body pins 234, wherein a bodypin 234 is mirrorly positioned on opposite sides of the handle portion202. The body pins 234 are engaged in the cable tension lever 230arcuate lever slots 236, such that cable tension lever 230 and cabletensioner 216 are movably connected to the handle portion 202.

In use, as the cable tension lever 230 is pivoted about the cabletensioner 216 from a first lever position L1 to a second lever positionL2, the body pins 234 traverse the arcuate lever slots 236, resulting ina translation of the cable tensioner 216 along the first end 218 of thecollett holder 208 from a first tensioner position T1 to a secondtensioner position T2. A tension bias member 238 is interposed betweenthe cable tensioner 216 and the handle portion 202, biasing the cabletensioner 216 into the first tensioner position T1. The cable tensionlever 230 includes tension indicating markings 240 along each of thearcuate lever slots 236. The tension markings 240 indicate the tensionto be applied to the cable.

Referring also to FIG. 34 an alternative cable tensioner 440 isprovided. Cable tensioner 440 is slidably positioned on a first end 218of the collett holder 208. The cable tensioner 440 defines a cablepassage longitudinally aligned with the longitudinal passage of thecollett holder 208. An end portion 442 of the cable tensioner 440includes a cleat 444 and a cleat stop 446. The cleat 444 is pivotallymounted to the cable tensioner 440, including a bias member 448 biasingthe cleat 444 into a closed position. A cable 450 is threadable betweenthe cleat 446 and the cleat stop 448, where in the closed position thecleat 446 imparts a force onto the cable 450, securing the cable 450 inthe cable tensioner 440.

The bias member 448 biases the cleat 444 such that in the closedposition the cable can be further drawn through the cable tensioner 440,for example, to position the fastener proximal to the tissue whileremoving any initial slack from the cable 450. However, the cleat 444prevents the cable 450 from being drawn back through the cable tensioner440. For example, the cleat 444 can include an arcuate contact surface452 such that the force imparted on the cable 450 in the closed positionincreases as the tension on the cable 450 increases, preventing thecable 450 from being drawn back through the cable tensioner 440. Thecleat arcuate surface 452 can further include a plurality of teeth 454,which can be utilized to grip cable 450.

Referring to FIGS. 18 and 20, a collett 242 is affixed to a second endportion 244 of the collett holder 208, opposite the cable tensioner 216.The collett 242 defines a collett passage longitudinally aligned withthe longitudinal passage of the collett holder 208 along the centrallongitudinal axis A. An end portion of the collett 242 is bisected,forming first and second collett arms 248 and 250. A gap portion 252 isprovided between the first and second collett arms 248 and 250. Each ofthe first and second collett arms 248 and 250 includes force applicationend portions 254 and 256. The force application end portions 254 and 256combine to form a bushing aperture 258 configured to received thebushing therein. The collett 242 is made of a semi-rigid material, suchthat the first and second collett arms 248 and 250 can be moved from anopen to a closed position, closing the gap 252 between the forceapplication end portions 254 and 256.

In use, the tensioning mechanism 204 is used to tension the cable. Thecable can include a single or multiple filaments. The cable is insertedthrough the medical device 200 along the central longitudinal axis A,through the collett 242, collett holder 208, and the cable tensioner216, positioning the bushing in the bushing aperture 258 and extendingthe cable through the cable aperture 224. To tension the cable, thecable tension lever 230 is actuated from the first lever position L1 tothe second lever position L2, sliding the cable tensioner 216 along thecollett holder 208 from the first tensioner position T1, into the handleportion 202 against the tension bias member 238, to the second tensionerposition T2. The cable is positioned through the radial groove 226 andwrapped about the circumferential groove 228 on the end portion 222 ofthe cable tensioner 216, securing the cable to the cable tensioner 216.The cable tension lever 230 is released, such that tension bias member238 biases the cable tensioner 216 from the second tensioner position T2towards the first tensioner position T1. The movement of the cabletensioner 216 towards the first tensioner position T1 applies a tensionto the cable, forcing the bushing into the second fastener. The appliedtension can be selected by actuating the cable tension lever 230 to thedesired tension marking 240.

Referring again to FIGS. 17 and 21, the crimping mechanism 206 includesan outer tube 260 slidingly positioned over the collett holder 208. Theouter tube 260 includes a first end 262 operably connected to a trigger264 and a second end 266 connected to a collett closer 268. The trigger264 is pivotally mounted in the handle portion 202, such that thetrigger 264 can be actuated from a first trigger position TR1 to asecond trigger position TR2. A locking mechanism 265 prevents thetrigger 264 from being actuated. The locking mechanism 265 is rotated todisengage the trigger 264, allowing actuation of the trigger 264.

The operable connection between the first end of the outer tube 262 andthe trigger 264 includes an outer tube ferrule 270 slidably positionedabout the collett holder 208 and affixed to the first end of the outertube 262. A tube bias member 272 is interposed between the handleportion 202 and the outer tube ferrule 270, such that the tube biasmember 272 biases the outer tube ferrule 270 and the outer tube 260 intoa first tube position P1. A pair of crimp cams 274 are pivotallyconnected to the handle portion 202 on opposite sides of the trigger264. The crimp cams 274 each include first edges 276 having an arcuatesection 278 for engaging the outer tube ferrule 270, where the crimpcams 274 are translatable with respect to the handle portion 202 from afirst cam position C1 to a second cam position C2.

An actuation of the trigger 264 from a first trigger position TR1 to asecond trigger position TR2 translated the crimp cams 274 with respectto the handle portion from a first cam position C1 to a second camposition C2 position. The arcuate sections 278 of the crimp cams 274engage the outer tube ferrule 270, translating the outer tube ferrule270 and the outer tube 260 along the collett holder 208 from the firsttube position P1 to a second tube position P2. As the trigger 264 isreleased, the tube bias member 272 biases the outer tube ferrule 270 andthe outer tube 260 from the second tube position P2 to the first tubeposition P1. Simultaneously, the crimp cams 274 and the trigger 264 aremoved to the first cam position C1 and the first trigger position TR1.

Referring to FIGS. 17 and 22, the collett closer 268 is positioned onthe outer tube 260 proximal to the force application end portions 254and 256 of the first and second collett arms 248 and 250. As the outertube 260 is moved from the first tube position P1 to the second tubeposition P2, the collett closer 268 is moved over the force applicationend portions 254 and 256. The collett closer 268 includes inner taperedsurfaces 280, such that the inner tapered surfaces 280 apply compressiveforces to the force application end portions 254 and 256 as the collettcloser 268 is moved over the force application end portions 254 and 256,closing the gap 252 there between.

In use, the trigger 264 is actuated from the first trigger position TR1to the second trigger position TR2. The actuation of the trigger 264slides the outer tube 260 along the collett holder 208 from the firsttube position P1 to the second tube position P2, moving collett closer268 about the force application end portions 254 and 256 of the firstand second collett arms 248 and 250. The inner tapered surfaces 280 ofthe collett closer 268 apply compressive forces to the first and secondforce application end portions 254 and 256, closing the gap 252 therebetween. The trigger 264 is released, allowing the tube bias member 272to bias the outer tube 260 from the second tube position P2 to the firsttube position P1, moving the collett closer 268 from the forceapplication end portions 254 and 256.

Referring to FIGS. 23-25, the crimping mechanism 206 can further includea cutting mechanism. The cutting mechanism includes a cut off cam 284slidingly positioned along a bottom portion of the collett holder 208.The cut off cam 284 includes a first end portion 286 positioned throughthe outer tube ferrule 270. A cut off cam ring 288 is slidablypositioned about the collett holder 208, engaging the first end portion286 of the cut off cam 284. The cut off cam ring 288 is positionedproximal to the trigger 264, such that as the trigger 264 is actuatedfrom the first trigger 264 position TR1 to the second trigger 264position TR2, a top portion 290 of the trigger 264 engages the cut offcam ring 288, sliding the cut off cam ring 288 and cut off cam 284 alongthe collett holder 208. A cut off bias member 291 is interposed betweenthe outer tube ferrule 270 and the cut off cam ring 288.

A cut off arm 292 is connected to the collett 242, at least partiallypositioned in the gap 252 between the first and second collett arms 248and 250. The cut off arm 292 includes a cutting head portion 294positioned proximal to the first and second force application endportions 254 and 256, at least partially positioned in the gap 252,interposed between the first and second collett arms 248 and 250. Thecutting head portion 294 includes a cutting edge 296, for cutting thecable, and a lower angular surface 298 for engagement by a second endportion 300 of the cut off cam 284.

In use, the trigger 264 is actuation from the first trigger position TR1to the second trigger position TR2. The actuation of the trigger 264results in the top portion 290 of the trigger 264 engaging the cut offcam ring 288, sliding the cut off cam ring 288 and cut off cam 284 alongthe collett holder 208. The second end portion 300 of the cut off cam284 engages the angular surface 298 of the cutting head 294, forcing thecutting edge 296 into the cable, cutting the cable. The trigger 264 isreleased, allowing the cut off bias member 291 to bias the cut off cam284 from the cutting head 294.

Referring to FIG. 26, in a method of use, the cable is passed throughthe bone and fracture, where a first fastener secures the cable on afirst side (fracture side) of the bone and a second fastener ispositioned about the cable on a second side of the bone, opposite thefirst fastener. A bushing is positioned onto the cable to secure thesecond fastener against the second side of the bone.

The cable is inserted through the medical device 200 along the centrallongitudinal axis “A”, through the collett 242, collett holder 208, andthe cable tensioner 216, positioning the bushing in the bushing aperture258 and extending the cable through the cable aperture 224. To tensionthe cable, the cable tension lever 230 is actuated from the first leverposition L1 to the second lever position L2, sliding the cable tensioner216 along the collett holder 208 from the first tensioner position T1,into the handle portion 202 against the tension bias member 238, to thesecond tensioner position T2. The cable is positioned through the radialgroove 226 and wrapped about the circumferential groove 228 on the endportion 222 of the cable tensioner 216, securing the cable to the cabletensioner 216. The cable tension lever 230 is released, such thattension bias member 238 biases the cable tensioner 216 from the secondtensioner position T2 towards the first tensioner position T1. Themovement of the cable tensioner 216 towards the first tensioner positionT1 applies a tension to the cable, pressing the bushing against thesecond fastener. The applied tension can be selected by actuating thecable tension lever 230 to the desired tension marking 240.

The trigger 264 is actuated from the first trigger position TR1 to thesecond trigger position TR2. The actuation of the trigger 264 slides theouter tube 260 along the collett holder 208 from the first tube positionP1 to the second tube position P2, moving collett closer 268 about theforce application end portions 254 and 256 of the first and secondcollett arms 248 and 250. The inner tapered surfaces 280 of the collettcloser 268 apply compressive forces to the first and second forceapplication end portions 254 and 256, compressing the first and secondforce application end portions 254 and 256 about the bushing positionedin the bushing aperture 258. The compressive forces crimp the bushingabout the cable, securing the bushing to the cable.

Simultaneously, the actuation of the trigger 264 results in the topportion 290 of the trigger 264 engaging the cut off cam ring 288,sliding the cut off cam ring 288 and cut off cam 284 along the collettholder 208. The second end portion 300 of the cut off cam 284 engagesthe angular surface 298 of the cutting head 294, forcing the cuttingedge 296 into the cable, cutting the cable.

In another embodiment a medical device 320 of the present inventionsecures a fastener against relative movement with respect to a suture,with the fastener itself being deformed. Medical device 320 issubstantially similar to medical device 200 and like reference numbershall be used to indicate like items.

Referring to FIGS. 27 and 28, medical device 320 includes collett 322.As with collett 242, previously disclosed and illustrated, collett 322is affixed to the second end portion 244 of the collett holder 208,opposite the cable tensioner 216. The collett 322 defines a collettpassage longitudinally aligned with the longitudinal passage of thecollett holder 208, along the central longitudinal axis A. An endportion of the collett 322 is bisected, forming first and second collettarms 324 and 326. A gap portion 328 is provided between the first andsecond collett arm 324 and 326. Each of the first and second collettarms 324 and 326 includes force application end portions 330 and 332.The force application end portions 330 and 332 combine to form afastener aperture 334 configured to receive the fastener therein. Theforce application end portions 330 and 332 each include opposingcompressive members 336 for compressing the fastener about the suture.

Referring to FIGS. 27 and 29, medical device 320 includes collett closer340. The collett closer 340 is positioned on the outer tube 260 proximalto the force application end portions 330 and 332 of the first andsecond collett arms 324 and 326. The collett closer 340 includes slottedsections 342 configured for receiving end portions of the fastenertherein. As the outer tube 260 is moved from the first tube position P1to the second tube position P2, the collett closer is moved over theforce application end portions 330 and 332. Similar to collett closer268, the collett closer 340 includes inner tapered surfaces 280 (SeeFIG. 22), such that the inner tapered surfaces 280 apply compressiveforces to the force application end portions 330 and 332 as the collettcloser 340 is moved over the force application end portions 330 and 332,closing the gap 328 there between.

Referring to FIGS. 30 and 31, in a method of use suture 360 is insertedthrough the bone 362 and fracture 364, where the suture 360 is threadedthrough a fastener 366 on a first side (fracture side) of the bone 362.The suture 360 is reinserted through the fracture 364 and bone 362, suchthat first and second ends 368 and 370 of the suture 360 extend from thebone 362. The first and second ends of the suture 368 and 370 arethreaded through a fastener 372, where the first end of the suture 368is threaded through a first aperture 374 in the fastener 372 and thesecond end of the suture 370 is threaded through a second aperture 376in the fastener 372.

Referring also to FIG. 26, the ends of the suture 368 and 370 areinserted through the medical device 320 along the central longitudinalaxis A, through the collett 322, collett holder 208, and the cabletensioner 216, positioning the fastener 372 in the fastener aperture 334and extending the ends of the suture 368 and 370 through the cableaperture 224. To tension the suture 360, the cable tension lever 230 isactuated from the first lever position L1 to the second lever positionL2, sliding the cable tensioner 216 along the collett holder 208 fromthe first tensioner position T1, into the handle portion 202 against thetension bias member 238, to the second tensioner position T2. The sutureends 368 and 370 are positioned through the radial groove 226 andwrapped about the circumferential groove 228 on the end portion 222 ofthe cable tensioner 216, securing the suture 360 to the cable tensioner216. The cable tension lever 230 is released, such that tension biasmember 238 biases the cable tensioner 216 from the second tensionerposition T2 towards the first tensioner position T1. The movement of thecable tensioner 216 towards the first tensioner position T1 appliestension to the suture 360, compressing the fastener 372 against the bone362. The applied tension can be selected by actuating the cable tensionlever 230 to the desired tension marking 240.

The trigger 264 is actuation from the first trigger position TR1 to thesecond trigger position TR2. The actuation of the trigger 264 slides theouter tube 260 along the collett holder 208 from the first tube positionP1 to the second tube position P2, moving collett closer 340 about theforce application end portions 330 and 332 of the first and secondcollett arms 324 and 326. The inner tapered surfaces 280 of the collettcloser 340 apply compressive forces to the first and second forceapplication end portions 330 and 332, compressing compressive members336 of the first and second force application end portions 330 and 332into the first and second fastener apertures 374 and 376. Thecompressive forces crimp the first and second fastener apertures 374 and376 about the suture ends 368 and 370, securing the fastener 372 to thesuture ends 368 and 370.

Simultaneously, the actuation of the trigger 264 results in the topportion 290 of the trigger 264 engaging the cut off cam ring 288,sliding the cut off cam ring 288 and cut off cam 284 along the collettholder 208. The second end portion 200 of the cut off cam 283 engagesthe angular surface 298 of the cutting head 294, forcing the cuttingedge 296 into the suture ends 268 and 270, cutting the suture ends 368and 370.

Referring to FIG. 32, similar to FIGS. 18 and 20, a collett 400 isaffixed to a second end portion 244 of the collett holder 208, oppositethe cable tensioner 216. The collett 400 defines a collett passagelongitudinally aligned with the longitudinal passage of the collettholder 208 along the central longitudinal axis A. An end portion of thecollett 400 is bisected, forming first and second collett arms 402 and404. A gap portion 406 is provided between the first and second collettarms 402 and 404. Each of the first and second collett arms 402 and 404includes force application end portions 408 and 410. The forceapplication end portions 408 and 410 combine to form a bushing aperture412 configured to received the bushing therein 414. The collett 400 ismade of a semi-rigid material, such that the first and second collettarms 402 and 404 can be moved from an open to a closed position, closingthe gap 406 between the force application end portions 408 and 410.

Referring also to FIG. 33, in a method of use, suture 416 is insertedthrough the bone 418 and fracture 420, where the suture 416 is threadedthrough a fastener 422 on a first side (fracture side) of the bone 424.The suture 416 is reinserted through the fracture 420 and bone 418, suchthat first and second ends 426 and 428 of the suture 416 extend from thebone 418. The first and second ends of the suture 426 and 428 arethreaded through a fastener 414, where the first and second ends 426 and428 of the suture 416 is threaded through an aperture 430 in thefastener 414.

Referring also to FIGS. 26 and 29, the ends of the suture 426 and 428are inserted through the medical device 320 along the centrallongitudinal axis A, through the collett 400, collett holder 208, andthe cable tensioner 216, positioning the fastener 414 in the fasteneraperture 412 and extending the ends of the suture 426 and 428 throughthe cable aperture 224. To tension the suture 416, the cable tensionlever 230 is actuated from the first lever position L1 to the secondlever position L2, sliding the cable tensioner 216 along the collettholder 208 from the first tensioner position T1, into the handle portion202 against the tension bias member 238, to the second tensionerposition T2. The suture ends 426 and 428 are positioned through theradial groove 226 and wrapped about the circumferential groove 228 onthe end portion 222 of the cable tensioner 216, securing the suture 360to the cable tensioner 216. The cable tension lever 230 is released,such that tension bias member 238 biases the cable tensioner 216 fromthe second tensioner position T2 towards the first tensioner positionT1. The movement of the cable tensioner 216 towards the first tensionerposition T1 applies tension to the suture 416, compressing the fastener414 against the bone 418. The applied tension can be selected byactuating the cable tension lever 230 to the desired tension marking240.

The trigger 264 is actuated from the first trigger position TR1 to thesecond trigger position TR2. The actuation of the trigger 264 slides theouter tube 260 along the collett holder 208 from the first tube positionP1 to the second tube position P2, moving collett closer 340 about theforce application end portions 408 and 410 of the first and secondcollett arms 402 and 404. The inner tapered surfaces 280 of the collettcloser 340 apply compressive forces to the first and second forceapplication end portions 408 and 410. The compressive forces crimp theaperture 430 about the suture ends 426 and 428, securing the fastener414 to the suture ends 426 and 428.

Referring to FIG. 36, a medical device 500 is provided for securing thebushing to the cable. The medical device 500 includes a handle portion502 having a tensioning mechanism 504, tensioning the cable and applyinga force to the bushing, and a crimping mechanism 506 for securing thebushing to the cable.

Referring also to FIGS. 37 and 38, the tensioning mechanism 504 includesa collett holder 508 defining a longitudinal passage along a centrallongitudinal axis A. The collett holder 508 is affixedly positionedthrough a top portion 510 of the handle portion 502. A cable tensioner512 is slidably positioned on a first end 514 of the collett holder 508.The cable tensioner 512 defines a cable passage longitudinally alignedwith the longitudinal passage of the collett holder 508. An end portion516 of the cable tensioner 512 includes a cable aperture for threadingthe cable there through. A radial groove and circumferential groove 518are provided on the end portion 516 of the cable tensioner 512, suchthat the cable can be wrapped about the circumferential groove 518 ofthe cable tensioner 512, thereby preventing relative movement betweenthe cable and the cable tensioner 512.

In an exemplary embodiment, the cable tensioner 512 can include aretention bushing 520 and a tension insert 522. The tension insert 522defines a cable passage longitudinally aligned with the longitudinalpassage of the cable tensioner 512. The retention bushing 520 ispositioned about a portion of the tension insert 522, where an endportion 524 is threaded into the end portion 516 of the cable tensioner512. An opposite end portion 526 of the tension insert 522 includes acable aperture 528 for threading the cable there through. A radialgroove 530 is provided on the end portion 526 of the cable tensioner 512and the retention bushing 520 and the tension insert 522 combine to forma circumferential groove 532, such that the cable can be wrapped aboutthe circumferential groove 532, thereby preventing relative movementbetween the cable and the cable tensioner 512.

A cable tension lever 534 is pivotally connected to the cable tensioner512 with a lever pin 536. The cable tension lever 534 is adjustablypositioned on the handle portion 502 with body pins 538, wherein a bodypin 538 is mirrorly positioned on opposite sides of the handle portion502. The body pins 538 are engaged in the cable tension lever 536arcuate lever slots 540, such that cable tension lever 534 and cabletensioner 512 are movably connected to the handle portion 502.

In use, as the cable tension lever 534 is pivoted about the cabletensioner 512 from a first lever position L1 to a second lever positionL2, the body pins 538 traverse the arcuate lever slots 540, resulting ina translation of the cable tensioner 512 along the first end 514 of thecollett holder 508 from a first tensioner position T1 to a secondtensioner position T2. A tension bias member 542 is interposed betweenthe cable tensioner 512 and the handle portion 502, biasing the cabletensioner 512 into the first tensioner position T1.

Referring to FIGS. 37 and 39, a collett 544 is affixed to a second endportion 546 of the collett holder 508, opposite the cable tensioner 512.The collett 544 defines a collett passage longitudinally aligned withthe longitudinal passage of the collett holder 508 along the centrallongitudinal axis A. An end portion of the collett 544 is bisected,forming first and second collett arms 548 and 550. A gap portion 552 isprovided between the first and second collett arms 548 and 550. Each ofthe first and second collett arms 548 and 550 includes force applicationend portions 554 and 556. The force application end portions 554 and 556combine to form a bushing aperture 558 configured to received thebushing therein. The collett 544 is made of a semi-rigid material, suchthat the first and second collett arms 548 and 550 can be moved from anopen to a closed position, closing the gap 552 between the forceapplication end portions 554 and 556.

In use, the tensioning mechanism 504 is used to tension the cable. Thecable can include single or multiple filaments. The cable is insertedthrough the medical device 500 along the central longitudinal axis A,through the collett 544, collett holder 508, and the cable tensioner512, positioning the bushing in the bushing aperture 558 and extendingthe cable through the cable aperture 530. To tension the cable, thecable tension lever 354 is actuated from the first lever position L1 tothe second lever position L2, sliding the cable tensioner 512 along thecollett holder 508 from the first tensioner position T1, into the handleportion 502 against the tension bias member 542, to the second tensionerposition T2. The cable is positioned through the radial groove 528 andwrapped about the circumferential groove 532 on the between theretention bushing 520 and the tension insert 522, securing the cable tothe cable tensioner 512. The cable tension lever 534 is released, suchthat tension bias member 542 biases the cable tensioner 512 from thesecond tensioner position T2 towards the first tensioner position T1.The movement of the cable tensioner 512 towards the first tensionerposition T1 applies a tension to the cable, forcing the bushing into thesecond fastener. The applied tension can be selected by actuating thecable tension lever 534 to the desired tension.

Referring to FIGS. 36 and 40, the crimping mechanism 506 includes anouter tube 560 slidingly positioned over the collett holder 508. Theouter tube 560 includes a first end 562 operably connected to a trigger564 and a second end 566 connected to a collett closer 568. The trigger264 is pivotally mounted in the handle portion 502, such that thetrigger 564 can be actuated from a first trigger position TR1 to asecond trigger position TR2. A locking mechanism 570 prevents thetrigger 564 from being actuated. The locking mechanism 570 is disengagedby rotating it away from the handle, where the locking mechanism issecured to the trigger with the locking pawl 572. (See also FIG. 37).

The operable connection between the first end of the outer tube 562 andthe trigger 564 includes an outer tube ferrule 574 slidably positionedabout the collett holder 408 and affixed to the first end of the outertube 562. A tube bias member 576 is interposed between the handleportion 502 and the outer tube ferrule 574, such that the tube biasmember 576 biases the outer tube ferrule 574 and the outer tube 560 intoa first tube position P1. A tube washer 578 can be provided between thetube ferrule 574 and the bias member 576.

An actuation of the trigger 564 from a first trigger position TR1 to asecond trigger position TR2 translates the outer tube ferrule 574 alongthe collett holder 208 from the first tube position P1 to a second tubeposition P2. In the second tube position P2 a tube pawl 580 engages theouter tube ferrule 574, hold the outer tube ferrule in the second tubposition P2.

Referring to FIGS. 36 and 42, the collett closer 568 is positioned onthe outer tube 560 proximal to the force application end portions 554and 556 of the first and second collett arms 548 and 550. As the outertube 560 is moved from the first tube position P1 to the second tubeposition P2, the collett closer 568 is moved over the force applicationend portions 554 and 556. The collett closer 568 includes inner taperedsurfaces 582, such that the inner tapered surfaces 580 apply compressiveforces to the force application end portions 554 and 556 as the collettcloser 568 is moved over the force application end portions 554 and 556,closing the gap 552 there between.

In use, the trigger 564 is actuated from the first trigger position TR1to the second trigger position TR2. The actuation of the trigger 564slides the outer tube 560 along the collett holder 508 from the firsttube position P1 to the second tube position P2, moving collett closer568 about the force application end portions 554 and 556 of the firstand second collett arms 548 and 550. The inner tapered surfaces 580 ofthe collett closer 568 apply compressive forces to the first and secondforce application end portions 554 and 556, closing the gap 552 therebetween.

Referring to FIGS. 41-43, the crimping mechanism 506 can further includea cutting mechanism. The cutting mechanism includes a pair of cut offcams 582 and 584 positioned in the collett gap 552. A pair of wedges 586and 588 are slidingly positioned along and on opposite sides of thecollett 550 and the collett holder 508. Each of the wedges 586 and 588include tapered ends 590 and 592 positioned proximal to the cut offarms, such that when the wedges are moved from a first wedge position W1to a second wedge position W2, the tapered ends 590 and 592 compress thecut off cams 582 and 584 together, cutting the cable.

The handle 502 further includes a wedge pusher 594 slidingly positionedabout the collett holder 508, adjacent to second ends 594 and 596 ofwedges 586 and 588. The wedge pusher 594 is slidable from a firstposition to a second position, such that the wedges 586 and 588 aremoved from the first wedge position W1 to the second wedge position W2.A rocker 596 is pivotally connected to the handle 502, such that anactuation of the rocker 596 from a first rocker position R1 to a secondrocker position R2, slides the wedge pusher 594 from the first positionto the second position, moving wedges 586 and 588 from the first wedgeposition W1 to the second wedge position W2

Referring to FIGS. 41 and 44, the locking mechanism 570 includes arocker kicker 598 pivotally affixed therein. The rocker kicker 598 isbiasedly connected to the locking mechanism 570, being held in a closedposition by a pin 600. When the trigger 564 is actuated from the firsttrigger position TR1 to the second trigger position TR2, the release 602engages the pin 600, releasing the rocker kicker 590.

The trigger 564 is released, allowing the trigger 564 to move from thesecond trigger position TR2 to the first trigger position TR1. Toactuate the cutting mechanism, the trigger is again moved from the firsttrigger position TR1 to the second trigger position TR2, such that therocker kicker 598 engages the rocker 596, pivoting the rocker 596 fromthe first rocker position R1 to the second rocker position. The rocker596 slides the wedge pusher 594 from the first position to the secondposition, moving wedges 586 and 588 from the first wedge position W1 tothe second wedge position W2, such that, the tapered ends 590 and 592compress the cut off cams 582 and 584 together, cutting the cable. Thetrigger 564 can then be released, releasing the crimped fastener.

It is also contemplated that the system and medical device of thepresent invention may be disposable or may be sterilized after use andreused.

The methods and devices of the present invention may be used inconjunction with any surgical procedure of the body. The repair,reconstruction, augmentation, and securing of tissue or an implant maybe performed in connection with surgery of a joint, bone, muscle,ligament, tendon, cartilage, capsule, organ, skin, nerve, vessel, orother body part. For example, tissue may be repaired, reconstructed,augmented, and secured following intervertebral disc surgery, kneesurgery, hip surgery, organ transplant surgery, bariatric surgery,spinal surgery, anterior cruciate ligament (ACL) surgery,tendon-ligament surgery, rotator cuff surgery, capsule repair surgery,fractured bone surgery, pelvic fracture surgery, avulsion fragmentsurgery, hernia repair surgery, and surgery of an intrasubstanceligament tear, annulus fibrosis, fascia lata, flexor tendons, etc. Inone particular application, an anastomosis is performed over a balloonand the methods and devices of the present invention are used to repairthe vessel.

Also, tissue may be repaired after an implant has been inserted withinthe body. Such implant insertion procedures include, but are not limitedto, partial or total knee replacement surgery, hip replacement surgery,bone fixation surgery, etc. The implant may be an organ, partial organgrafts, tissue graft material (autogenic, allogenic, xenogenic, orsynthetic), collagen, a malleable implant like a sponge, mesh,bag/sac/pouch, collagen, or gelatin, or a rigid implant made of metal,polymer, composite, or ceramic. Other implants include biodegradableplates, porcine or bovine patches, metallic fasteners, compliantbearings for one or more compartments of the knee, nucleus pulposusprosthetic, stent, tissue graft, tissue scaffold, biodegradable collagenscaffold, and polymeric or other biocompatible scaffold. The scaffoldmay include fetal cells, stem cells, embryonal cells, enzymes, andproteins.

The present invention further provides flexible and rigid fixation oftissue. Both rigid and flexible fixation of tissue and/or an implantprovides compression to enhance the healing process of the tissue. Afractured bone, for example, requires the bone to be realigned andrigidly stabilized over a period time for proper healing. Also, bonesmay be flexibly secured to provide flexible stabilization between two ormore bones. Soft tissue, like muscles, ligaments, tendons, skin, etc.,may be flexibly or rigidly fastened for proper healing. Flexiblefixation and compression of tissue may function as a temporary strut toallow motion as the tissue heals. Furthermore, joints which include hardand soft tissue may require both rigid and flexible fixation to enhancehealing and stabilize the range of motion of the joint. Flexiblefixation and compression of tissue near a joint may provide motion inone or more desired planes. The fasteners described herein andincorporated by reference provide for both rigid and flexible fixation.

It is contemplated that the devices and methods of the present inventionbe applied using minimally invasive incisions and techniques to preservemuscles, tendons, ligaments, bones, nerves, and blood vessels. A smallincision(s) may be made adjacent the damaged tissue area to be repaired,and a tube, delivery catheter, sheath, cannula, or expandable cannulamay be used to perform the methods of the present invention. U.S. Pat.No. 5,320,611 entitled, Expandable Cannula Having Longitudinal Wire andMethod of Use, discloses cannulas for surgical and medical useexpandable along their entire lengths. The cannulas are inserted throughtissue when in an unexpanded condition and with a small diameter. Thecannulas are then expanded radially outwardly to give a full-sizeinstrument passage. Expansion of the cannulas occurs against theviscoelastic resistance of the surrounding tissue. The expandablecannulas do not require a full depth incision, or at most require only aneedle-size entrance opening.

Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730 disclosecannulas for surgical and medical use expandable along their entirelengths. The cannula has a pointed end portion and includes wires havingcores which are enclosed by jackets. The jackets are integrally formedas one piece with a sheath of the cannula. The cannula may be expandedby inserting members or by fluid pressure. The cannula is advantageouslyutilized to expand a vessel, such as a blood vessel. An expandablechamber may be provided at the distal end of the cannula. The abovementioned patents are hereby incorporated by reference.

In addition to using a cannula with the methods of the presentinvention, an introducer may be utilized to position fasteners at aspecific location within the body. U.S. Pat. No. 5,948,002 entitledApparatus and Method for Use in Positioning a Suture Anchor, disclosesdevices for controlling the placement depth of a fastener. Also, U.S.patent application Ser. No. 10/102,413 discloses methods of securingbody tissue with a robotic mechanism. The above-mentioned patent andapplication are hereby incorporated by reference. Another introducer orcannula which may be used with the present invention is the VersaStep®System by Tyco® Healthcare.

The present invention may also be utilized with minimally invasivesurgery techniques disclosed in U.S. patent application Ser. No.10/191,751 and U.S. Pat. Nos. 6,702,821 and 6,770,078. These patentdocuments disclose, inter alia, apparatus and methods for minimallyinvasive joint replacement. The femoral, tibial, and/or patellarcomponents of a knee replacement may be fastened or locked to each otherand to adjacent tissue using fasteners disclosed herein and incorporatedby reference. Furthermore, the methods and devices of the presentinvention may be utilized for repairing, reconstructing, augmenting, andsecuring tissue or implants during and “on the way out” of a kneereplacement procedure. For example, the anterior cruciate ligament andother ligaments may be repaired or reconstructed; quadriceps mechanismsand other muscles may be repaired. The patent documents mentioned aboveare hereby incorporated by reference.

In addition, intramedullary fracture fixation and comminuted fracturefixation may be achieved with the devices and methods of the presentinvention. For example, a plate or rod may be positioned within oragainst the fractured bone. A fastener may be driven through or aboutthe bone and locked onto the plate, rod, or another fastener.

It is further contemplated that the present invention may be used inconjunction with the devices and methods disclosed in U.S. Pat. No.5,329,846 entitled, Tissue Press and System, and U.S. Pat. No. 5,269,785entitled, Apparatus and Method for Tissue Removal. For example, animplant secured within the body using the present invention may includetissue harvested, configured, and implanted as described in the patents.The above-mentioned patents are hereby incorporated by reference.

Furthermore, it is contemplated that the methods of the presentinvention may be performed under indirect visualization, such asendoscopic guidance, computer assisted navigation, magnetic resonanceimaging, CT scan, ultrasound, fluoroscopy, X-ray, or other suitablevisualization technique. The implants, fasteners, fastener assemblies,and sutures of the present invention may include a radiopaque materialfor enhancing indirect visualization. The use of these visualizationmeans along with minimally invasive surgery techniques permitsphysicians to accurately and rapidly repair, reconstruct, augment, andsecure tissue or an implant within the body. U.S. Pat. Nos. 5,329,924;5,349,956; and 5,542,423 disclose apparatus and methods for use inmedical imaging. Also, the present invention may be performed usingrobotics, such as haptic arms or similar apparatus. The above-mentionedpatents are hereby incorporated by reference.

All references cited herein are expressly incorporated by reference intheir entirety.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention. Therefore, it will be understood that theappended claims are intended to cover all such modifications andembodiments which come within the spirit and scope of the presentinvention.

What is claimed is:
 1. A tissue fixation system comprising: an elongatefastening member; and a fastener positionable on the elongated fasteningmember and movable from a first orientation to a second orientation, thefastener having a body with a tissue contacting surface that includes agroove configured and dimensioned to receive a portion of the elongatefastening member in the first orientation.
 2. The tissue fixation systemof claim 1 wherein the fastener body has a free surface opposite thetissue contacting surface, the free surface including a channelconfigured and dimensioned to receive a portion of the elongate memberin the first orientation.
 3. The tissue fixation system of claim 2wherein the fastener body includes a through bore extending from thetissue contacting surface through the free surface.
 4. The tissuefixation system of claim 3 wherein the fastener body includes leadingand trailing ends, the groove terminating at the through bore andextending toward one of the leading and trailing ends and the channelterminating at the through bore and extending toward the other of theleading and trailing ends.
 5. The tissue fixation system of claim 4wherein the groove extends toward the leading end and the channelextends toward the trailing end.
 6. The tissue fixation system of claim5 wherein the free surface of the fastener body includes a wellsurrounding the through bore.
 7. The tissue fixation system of claim 6wherein a distal end of the elongate fastening member includes a stoplarger than the through bore.
 8. The tissue fixation system of claim 7wherein the well is configured and dimensioned to receive at least aportion of the stop.
 9. The tissue fixation system of claim 8 whereinthe leading end of the fastener body is tapered.
 10. The tissue fixationsystem of claim 1 further comprising a biasing means maintaining thefastener in the first orientation.
 11. The tissue fixation system ofclaim 10 wherein the biasing means comprises an adhesive between thegroove and the portion of the elongate fastening member received in thegroove.
 12. The tissue fixation system of claim 10 wherein the biasingmeans comprises a frangible connection between the groove and theportion of the elongate fastening member received in the groove.
 13. Atissue fixation system for fixation of a first tissue member to a secondtissue member, comprising: an elongate fastener member positionablethough the first and second tissues members and including first andsecond ends, such that the first and second tissue members areinterposed between the first and second ends of the elongate fastenermember; a first fastener positionable on the first end on the elongatefastener member, adjacent to the first tissue member; and a secondfastener positionable on the second end on the elongate fastener member,adjacent to the second tissue member; wherein a tension is providedthrough the elongate fastener member between the first and secondfasteners, affixing the first tissue member to the second tissue member.14. A tissue fixation system as set forth in claim 13 wherein the firstfastener is moveable with respect to the elongate fastener member from afirst orientation to a second orientation, the first fastener having abody with a tissue contacting surface that includes a groove configuredand dimensioned to receive a portion of the elongate fastener member inthe first orientation.
 15. The tissue fixation system as set forth inclaim 14 wherein the first fastener body has a free surface opposite thetissue contacting surface, the free surface including a channelconfigured and dimensioned to receive a portion of the elongate fastenermember in the first orientation.
 16. The tissue fixation system as setforth in claim 15 wherein the first fastener body includes a throughbore extending from the tissue contacting surface through the freesurface, through which the elongate fastener member extends.
 17. Thetissue fixation system as set forth in claim 14 wherein the firstfastener body includes leading and trailing ends, the groove terminatingat the through bore and extending toward one of the leading and trailingends and the channel terminating at the through bore and extendingtoward the other of the leading and trailing ends.
 18. The tissuefixation system as set forth in claim 17 wherein the groove extendstoward the leading end and the channel extends toward the trailing end.19. The tissue fixation system as set forth in claim 18 wherein the freesurface of the first fastener body includes a well surrounding thethrough bore.
 20. The tissue fixation system as set forth in claim 19wherein the first end of the elongate fastener member includes a stoplarger than the through bore.